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Agencija za lijekove i medicinske proizvode (ALMP)   Doc. dr. sc. Siniša Tomić Ravnatelj ALMP
Agencija za lijekove i medicinske proizvode OSNOVANA  1. listopada 2003 . Agencija za lijekove i  medicinske proizvode  Republike Hrvatske Hrvatski zavod za  kontrolu  lijekova Hrvatski zavod za  kontrolu  imunobioloških preparata
Agencija za lijekove  i medicinske proizvode (ALMP) Provodi regulatornu kontrolu na području:    LIJEKOVA   MED. PROIZVODA  HOMEOPAT. PROIZVODA
Ustrojstvene jedinice   Agencije ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Djelatnosti Agencije Ocjena dokumentacije -davanje odobrenja (lijek)  -upis u očevidnik (medicinski proizvod) Provjera kakvoće lijekova, cjepiva i krvnih derivata Dozvole -proizvodne -za promet na malo/veliko -uvoz/izvoz Međunarodna suradnja  i usklađivanje s EU propisima Hrvatska  farmakopeja Nadzor nad  nuspojavama Praćenje potrošnje lijekova Administrativna podrška-Središnje etičko povjerenstvo (SEP) Informiranje o lijekovima
Profil stručnjaka u Agenciji
DAVANJE ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Zašto se lijekovi odobravaju? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Obnove i izmjene odobrenja 0 godina 5 godina 1. odobrenje obnova izmjene izmjene 210 dana (180/150 dana) 180 dana 90 dana
PROVJERA KAKVOĆE LIJEKA
Tko obavlja provjeru kakvoće lijeka? ,[object Object],[object Object]
Provjera kakvoće lijeka Kakvoća lijekova (Agencija) REDOVITA   POSEBNA IZ PROMETA IZVANREDNA SVAKA SERIJA LIJEKA  UVEZENA U HRVATSKU PRVA SERIJA LIJEKA  NAKON ODOBRENJA SVAKA SERIJA  IMUNOLOŠKOG LIJEKA ILI LIJEKA IZ KRVI ILI PLAZME DRUGI LIJEK   ( uz odobrenje ministra  zdravstva ) FARMACEUTSKI  INSPEKTOR ILI  AGENCIJA NAJMANJE JEDNOM  U 5 GODINA NA ZAHTJEV AGENCIJE  ILI MINISTARSTVA SUMNJA U KAKVOĆU ZA EU LIJEKOVE  PRIHVAĆA SE  CERTIFIKAT KAKVOĆE ROK : 30  DANA ROK : EU LIJEKOVI:  8  DANA OSTALI : 30  DANA
NUSPOJAVE LIJEKOVA (Farmakovigilancija)
Novi termin - farmakovigilancija ,[object Object],[object Object]
Farmakovigilancija ,[object Object],[object Object],[object Object],[object Object]
Odsjek za farmakovigilanciju ,[object Object],[object Object]
Broj spontanih prijava nuspojava +  180 % Više od 60 radionica o važnosti prijavljivanja nuspojava
[object Object]
Medicinski proizvod   Medicinski proizvod  jest instrument, naprava, uređaj, program, materijal ili drugi proizvod za humanu uporabu koji svoju osnovnu namjenu ne postiže na temelju farmakoloških, imunoloških ili metaboličkih svojstava i koji se upotrebljava samostalno ili u kombinaciji s programskom podrškom neophodnom za njegovu pravilnu uporabu.
Medicinski proizvodi ,[object Object],[object Object],[object Object]
[object Object]
  Zakon o lijekovima ,[object Object],[object Object],[object Object],[object Object],[object Object]
Međunarodna suradnja WHO AGENCIJA ZA LIJEKOVE I MEDICINSKE PROIZVODE
KOMUNIKACIJSKA STRATEGIJA
Informiranje Internetska stranica Agencije i drugi zdravstveni portali Farmaceutski glasnik, Pharmaca i drugi stručni časopisi Publikacije i oglasi Sredstva javnog priopćavanja Predavanja 0-24 h
Godišnji sastanak Nacionalnih tajništava  Europske farmakopeje (Rijeka) 2007. Farmakopejski dani Simpozij o Hrvatskoj farmakopeji (Rijeka) 3. konferencija Europske udruge proizvođača  generičkih lijekova za jugoistočnu Europu (Split) Tečaj i seminar iz  područja farmakovigilancije (Spačva) Edukacije
Edukacije ,[object Object],Konferencija „EU regulatorna mreža – Izazovi i mogućnosti za Hrvatsku“ (Rijeka)   Seminar "Novosti u europskoj farmakovigilanciji i upravljanju rizikom" (Vukovar)
Internetska stranica Agencije www.almp.hr
NAJAVA DOGAĐANJA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Agencija za lijekove i medicinske proizvode Ksaverska cesta 4 Zagreb www.almp.hr

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Agencija Za Lijekove I Medicinske Proizvode

  • 1. Agencija za lijekove i medicinske proizvode (ALMP) Doc. dr. sc. Siniša Tomić Ravnatelj ALMP
  • 2. Agencija za lijekove i medicinske proizvode OSNOVANA 1. listopada 2003 . Agencija za lijekove i medicinske proizvode Republike Hrvatske Hrvatski zavod za kontrolu lijekova Hrvatski zavod za kontrolu imunobioloških preparata
  • 3. Agencija za lijekove i medicinske proizvode (ALMP) Provodi regulatornu kontrolu na području: LIJEKOVA MED. PROIZVODA HOMEOPAT. PROIZVODA
  • 4.
  • 5. Djelatnosti Agencije Ocjena dokumentacije -davanje odobrenja (lijek) -upis u očevidnik (medicinski proizvod) Provjera kakvoće lijekova, cjepiva i krvnih derivata Dozvole -proizvodne -za promet na malo/veliko -uvoz/izvoz Međunarodna suradnja i usklađivanje s EU propisima Hrvatska farmakopeja Nadzor nad nuspojavama Praćenje potrošnje lijekova Administrativna podrška-Središnje etičko povjerenstvo (SEP) Informiranje o lijekovima
  • 7. DAVANJE ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
  • 8.
  • 9. Obnove i izmjene odobrenja 0 godina 5 godina 1. odobrenje obnova izmjene izmjene 210 dana (180/150 dana) 180 dana 90 dana
  • 11.
  • 12. Provjera kakvoće lijeka Kakvoća lijekova (Agencija) REDOVITA POSEBNA IZ PROMETA IZVANREDNA SVAKA SERIJA LIJEKA UVEZENA U HRVATSKU PRVA SERIJA LIJEKA NAKON ODOBRENJA SVAKA SERIJA IMUNOLOŠKOG LIJEKA ILI LIJEKA IZ KRVI ILI PLAZME DRUGI LIJEK ( uz odobrenje ministra zdravstva ) FARMACEUTSKI INSPEKTOR ILI AGENCIJA NAJMANJE JEDNOM U 5 GODINA NA ZAHTJEV AGENCIJE ILI MINISTARSTVA SUMNJA U KAKVOĆU ZA EU LIJEKOVE PRIHVAĆA SE CERTIFIKAT KAKVOĆE ROK : 30 DANA ROK : EU LIJEKOVI: 8 DANA OSTALI : 30 DANA
  • 14.
  • 15.
  • 16.
  • 17. Broj spontanih prijava nuspojava + 180 % Više od 60 radionica o važnosti prijavljivanja nuspojava
  • 18.
  • 19. Medicinski proizvod Medicinski proizvod jest instrument, naprava, uređaj, program, materijal ili drugi proizvod za humanu uporabu koji svoju osnovnu namjenu ne postiže na temelju farmakoloških, imunoloških ili metaboličkih svojstava i koji se upotrebljava samostalno ili u kombinaciji s programskom podrškom neophodnom za njegovu pravilnu uporabu.
  • 20.
  • 21.
  • 22.
  • 23. Međunarodna suradnja WHO AGENCIJA ZA LIJEKOVE I MEDICINSKE PROIZVODE
  • 25. Informiranje Internetska stranica Agencije i drugi zdravstveni portali Farmaceutski glasnik, Pharmaca i drugi stručni časopisi Publikacije i oglasi Sredstva javnog priopćavanja Predavanja 0-24 h
  • 26. Godišnji sastanak Nacionalnih tajništava Europske farmakopeje (Rijeka) 2007. Farmakopejski dani Simpozij o Hrvatskoj farmakopeji (Rijeka) 3. konferencija Europske udruge proizvođača generičkih lijekova za jugoistočnu Europu (Split) Tečaj i seminar iz područja farmakovigilancije (Spačva) Edukacije
  • 27.
  • 29.
  • 30. Agencija za lijekove i medicinske proizvode Ksaverska cesta 4 Zagreb www.almp.hr